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Oxytocin 10 [USP'U]/mL Injection — NDC 00143-9742-25 package photo

Oxytocin 10 [USP'U]/mL Injection

by West-Ward Pharmaceuticals Corp · 25 VIAL in 1 CARTON (0143-9742-25) / 10 mL in 1 VIAL (0143-9742-01)
NDC 00143-9742-25
🏷️ FDA NDC (as labeled) 0143-9742-25 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0143-9742-25
Product NDC 0143-9742
11-digit billing NDC 00143974225
RxCUI 238013, 1791721
UNII 1JQS135EYN
Application # ANDA200219
SPL Set ID d16a48c5-6b71-40a0-bcda-204f043fe832
Established class (EPC) Oxytocic
Physiologic effect Increased Uterine Smooth Muscle Contraction or Tone
Chemical class Oxytocin
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-02-13
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance OXYTOCIN
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0143-9742-25 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00143-9742-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Oxytocic class.

Pharmacologic class Oxytocic
Drug family (ATC) Oxytocin and analogues
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerWest-Ward Pharmaceuticals Corp
Application holderHIKMA FARMACEUTICA PORTUGAL SA
FDA applicationANDA200219 (ANDA)
Labeler code00143
First marketedFeb 2013
Product typeHuman Prescription Drug
Portfolio10 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Oxytocin injection is used to begin or improve contractions during labor. Oxytocin also is used to reduce bleeding after childbirth. It also may be used along with other medications or procedures to end a pregnancy. Oxytocin is in a class of medications called oxytocic hormones. It works by stimulating uterine contractions.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That's a really common question. Oxytocin is used when there's a medical reason to start or speed up labor — for example, if your water has broken and contractions haven't started,...
  • Why am I being given oxytocin? I thought labor was supposed to start on its own.
  • For starting or strengthening labor, oxytocin is always given through an IV drip in your arm using a pump that carefully controls the flow rate. Your contractions and your baby's h...
  • The most common ones are nausea and vomiting. Your heart rate and blood pressure will be watched for any changes. If the contractions become too strong or too frequent, that's some...
📖 Read our full Oxytocin Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 500 mg / 1 mL UNII HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxytocin 10 [USP'U]/mLthis 00143-9742-25 West-Ward 25 vials — AP FDA listed —
Pitocin 10 [iU]/mL 42023-0116-02 Par 25 vials — AP FDA listed —
Pitocin 10 [iU]/mL 42023-0130-06 Par 6 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 63323-0012-07 Fresenius 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 00143-9743-25 West-Ward 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 55154-9584-05 Cardinal 5 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 70518-4233-00 REMEDYREPACK 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 65219-0021-01 Fresenius 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oxytocin — the ingredient across all brands.

Top reported reactions

Foetal Exposure During Pregnancy443
Premature Baby206
Hypotension191
Premature Delivery160
Drug Exposure During Pregnancy144
Postpartum Haemorrhage144
Maternal Exposure During Delivery134

Age at onset

Neonate208
Infant9
Child2
Adult278
Elderly21

Reporter sex

2,982 reports
Male · 13%
Female · 86%
Unknown · 1%

Serious outcomes

Hospitalization888
Life-threatening314
Death150
Disabling37
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 237 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00143-9742-25 You're viewing this 25 VIAL in 1 CARTON (0143-9742-25) / 10 mL in 1 VIAL (0143-9742-01) 2013-02-13 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0143-9742-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00143-9742-25, written without dashes as 00143974225. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00143-9742-25, the first segment (00143) is the labeler code FDA assigned to West-Ward Pharmaceuticals Corp; the middle segment (9742) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by West-Ward Pharmaceuticals Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
West-Ward Pharmaceuticals Corp is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 67 words ▾

IMPORTANT NOTICE Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE IMPORTANT NOTICE Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.

Antepartum Oxytocin Injection, USP (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.

In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.

Postpartum Oxytocin Injection, USP (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.

Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.

An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances. To prepare the usual solution for intravenous infusion - one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.

The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 mU/min.

The dose may be gradually increased in increments of no more than 1 to 2 mU/min, until a contraction pattern has been established which is similar to normal labor. The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored. The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress.

Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician. Control of Postpartum Uterine Bleeding Intravenous Infusion (Drip Method) – To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.

Intramuscular Administration – 1 mL (10 units) of oxytocin can be given after delivery of the placenta. Treatment of Incomplete or Inevitable Abortion Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 100 words ▾

CONTRAINDICATIONS Oxytocin injection (synthetic) is contraindicated in any of the following conditions: Significant cephalopelvic disproportion; Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies; In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; In cases of fetal distress where delivery is not imminent; Prolonged use in uterine inertia or severe toxemia; Hypertonic uterine patterns; Patients with hypersensitivity to the drug; Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.

⚠️ Warnings 28 words ▾

WARNINGS Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route, and with adequate medical supervision in a hospital.

🤒 Adverse Reactions 145 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction Nausea Postpartum hemorrhage Vomiting Cardiac arrhythmia Premature ventricular contractions Fatal afibrinogenemia Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred, and is associated with a slow oxytocin infusion over a 24-hour period.

Maternal death due to oxytocin-induced water intoxication has been reported. The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility Due to use of oxytocin in the mother Bradycardia Neonatal retinal hemorrhage Premature ventricular contractions and other arrhythmias Low Apgar scores at five minutes Permanent CNS or brain damage Neonatal jaundice Fetal death

🔄 Drug Interactions 62 words ▾

Drug Interactions Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.

🤰 Pregnancy 78 words ▾

Pregnancy Category C There are no known indications for use of oxytocin in the first and second trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated. Nonteratogenic Effects- See ADVERSE REACTIONS in the fetus or infant.

Labor and Delivery- See INDICATIONS AND USAGE .

🆘 Overdosage 115 words ▾

OVERDOSAGE Overdosage with oxytocin injection (synthetic) depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H 2 O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, uteroplacental hypoperfusion and variable deceleration of fetal heart, fetal hypoxia, hypercapnia or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of oxytocin, is a serious complication that may occur if large doses (40 to 50 milliunits/minute) are infused for long periods.

Management consists of immediate discontinuation of oxytocin, and symptomatic and supportive therapy.

🧬 Clinical Pharmacology 92 words ▾

CLINICAL PHARMACOLOGY Oxytocin injection (synthetic) acts on the smooth muscle of the uterus to stimulate contractions; response depends on the uterine threshold of excitability. It exerts a selective action on the smooth musculature of the uterus, particularly toward the end of pregnancy, during labor and immediately following delivery. Oxytocin stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions and raises the tone of the uterine musculature.

Synthetic oxytocin does not possess the cardiovascular effects, such as elevation of blood pressure, as exhibited by vasopressin found in posterior pituitary injection.

📦 How Supplied / Storage and Handling 77 words ▾

HOW SUPPLIED Oxytocin Injection, USP (synthetic) is supplied as follows: NDC 0143-9743-25 Package of 25. 1 mL fill in a 2 mL vial, 10 USP Units per mL. NDC 0143-9742-25 Package of 25. 10 mL fill in a 10 mL vial, 10 USP Units per mL. Discard unused portion. Use only if solution is clear and seal is intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Do not permit to freeze.

📋 Description 78 words ▾

DESCRIPTION Each mL of Oxytocin Injection, USP (synthetic), intended for intravenous infusion or intramuscular injection, possesses an oxytocic activity equivalent to 10 USP Oxytocin Units and contains chlorobutanol (chloral derivative) 0.5%. This product may contain up to 12.5% decomposition products/‌impurities. Oxytocin injection (synthetic) is a sterile, clear, colorless solution of oxytocin in Water for Injection, USP prepared by synthesis.

Acetic acid may have been added for pH adjustment (pH 3.0 - 5.0). The structural formula is: Structural formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00143-9729-05 · Hikma 00143-9743-25 · West-Ward →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.